Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

OCT and Microperimetry in Patients With Active Neovascular ARMD (CORFI) (CORFI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435926
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:

ARMD is the main cause of visual disability after 50 years old in France. Patients with active neovascular ARMD are treated with intravitreal injections of antiVEGF. Reinjections criteria are decrease of best corrected visual acuity or active neovascularization's signs (mostly found on macular OCT but also on angiography when necessary).

The aim of this study is to evaluate the link between active neovascularization found on OCT and eye fixation quality measured with microperimetry in ARMD patients treated with antiVEGF.

Quality of eye fixation and exudative signs presents or not present on OCT will be gathered at each consultation over the two-years follow-up for each patient. The mean central retinal sensitivity, the best corrected visual acuity and the bivariate contour ellipse area will also be gathered.

In case no link will be found, for instance bad fixation quality without exudative signs on OCT or good fixation stability despite exudative signs on OCT, microperimetry should have an interest to improve reinjections criteria with a treatment more suitable to the patient.


Condition or disease
Choroidal Neovascularization, Visual Field, Visual Acuity

Layout table for study information
Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Link Between Active Neovascularization Found on OCT and Eye Fixation Quality Measured With Microperimetry in ARMD Patients Treated With antiVEGF
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : February 13, 2021
Estimated Study Completion Date : February 13, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. fixation stability measured by microperimetry and exudative signs on OCT [ Time Frame: 2 years ]

    quality of eye fixation and exudative signs presents or not present on OCT will be gathered at each consultation over the two-years follow-up.

    The fixation stability is classified as follows:

    • Stable if more than 75% of the fixation points are contained inside the circle of 2 degrees of diameter
    • Relatively unstable if more than 75% of the fixation points are contained within the circle of 4 degrees of diameter and less than 75% contained within that of 2 degrees of diameter
    • Unstable if less than 75% of the fixation points are contained within the circle of 4 degrees of diameter


Secondary Outcome Measures :
  1. Bivariate Contour Ellipse Area (BCEA) value [ Time Frame: 2 years ]
    BCEA will be gathered at each consultation over the two-years follow-up

  2. mean central retinal sensitivity [ Time Frame: 2 years ]
    mean central retinal sensitivity will be gathered at each consultation over the two-years follow-up

  3. Best Corrected Visual Acuity (BCVA) [ Time Frame: 2 years ]
    BCVA will be gathered at each consultation over the two-years follow-up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with active neovascular ARMD treated with antiVEGF
Criteria

Inclusion Criteria:

  • patients > 50 years old,
  • With neovascular ARMD
  • who need an induction treatment (de novo patients or patients who had their last intravitreal injection of antiVEGF more than 6 months ago)

Exclusion Criteria:

  • Other maculopathies
  • Severe glaucoma with central visual field defect
  • Diabetic patients
  • Corneal, lens or vitreous opacities interfering in OCT analysis
  • Attention or comprehension deficit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435926


Contacts
Layout table for location contacts
Contact: NATHALIE LABROUSSE, Dr +33681529217 nathalie-isa.labrousse@orange.fr
Contact: PIERRE-YVES ROBERT, Pr pierre-yves.robert@unilim.fr

Locations
Layout table for location information
France
University Hospital Recruiting
Limoges, France, 87042
Contact: NATHALIE LABROUSSE, Dr    +33681529217    nathalie-isa.labrousse@orange.fr   
Contact: PIERRE-YVES ROBERT, Pr       pierre-yves.robert@unilim.fr   
Sponsors and Collaborators
University Hospital, Limoges
Layout table for additonal information
Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT03435926    
Other Study ID Numbers: I16021 (CORFI)
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Choroidal Neovascularization
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases